A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults

• ClinicalTrials.gov Identifier: NCT05923424
• Recruitment Status: Active, not recruiting
• First Posted: June 28, 2023
• Last Update Posted: April 2, 2024
• Sponsor: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

Tracking Information

• First Submitted Date: June 20, 2023
• First Posted Date: June 28, 2023
• Last Update Posted Date: April 2, 2024
• Actual Study Start Date: November 28, 2023
• Estimated Primary Completion Date: April 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2023)

• Occurrence of all treatment emergent adverse events (TEAEs) [ Time Frame: Through approximately day 365 ]
• Severity of all TEAEs [ Time Frame: Through approximately day 365 ]
• Occurrence of all treatment emergent serious adverse events (TE-SAEs) [ Time Frame: Through approximately day 365 ]
• Severity of all TE-SAEs [ Time Frame: Through approximately day 365 ]

Original Primary Outcome Measures (submitted: June 20, 2023)

• Occurrence of all treatment emergent adverse events (TEAEs) [ Time Frame: Through approximately day 365 ]
• Severity of all TEAEs [ Time Frame: Through approximately day 365 ]
• Occurrence of all treatment emergent serious adverse events (TE-SAEs) [ Time Frame: Through approximately day 365 ]
• Severity of all SAEs [ Time Frame: Through approximately day 365 ]

Current Secondary Outcome Measures (submitted: June 20, 2023)

• Concentrations of REGN17092 in serum over time [ Time Frame: Through approximately day 365 ]
• Incidence of Anti-drug antibodies (ADAs) to REGN17092 over time [ Time Frame: Through approximately day 365 ]
• Titer of ADAs to REGN17092 over time [ Time Frame: Through approximately day 365 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Trial to Learn if Different Doses of REGN17092 Are Safe in Healthy Adults
• Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN17092, an Anti-SARS-CoV-2 (COVID-19) Monoclonal Antibody, in Adult Healthy Volunteers

Brief Summary

The purpose of this study is to learn about the safety and tolerability of different doses of REGN17092 administered with a needle either under the skin (called "subcutaneous") or into a vein (called an "infusion") in healthy participants. This is the first time that REGN17092 will be given to people.

Other aims are to assess:

• How much of the study drug is in the blood at different times
• Whether the body makes its own antibodies against the study drug (which could make the drug less effective or lead to side effects)

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Healthy Volunteers

Intervention

• Drug: REGN17092
  Single ascending intravenous (IV) or subcutaneous (SC) administration per the protocol
• Drug: Matching Placebo
  Single ascending IV or SC administration per the protocol

Study Arms

• Experimental: Cohort 1 Mid IV Dose
  Randomized 6:2 for single ascending dose
  Interventions:

  • Drug: REGN17092
  • Drug: Matching Placebo
• Experimental: Cohort 3 High IV Dose
  Randomized 6:2 for single ascending dose
  Interventions:

  • Drug: REGN17092
  • Drug: Matching Placebo
• Experimental: Cohort 5 Higher IV Dose
  Randomized 6:2 for single ascending dose
  Interventions:

  • Drug: REGN17092
  • Drug: Matching Placebo
• Experimental: Cohort 6 Low IV Dose
  Randomized 6:2 for single ascending dose
  Interventions:

  • Drug: REGN17092
  • Drug: Matching Placebo
• Experimental: Cohort 2 Mid SC Dose
  Randomized 6:2 for single ascending dose
  Interventions:

  • Drug: REGN17092
  • Drug: Matching Placebo
• Experimental: Cohort 4 High SC Dose
  Randomized 6:2 for single ascending dose
  Interventions:

  • Drug: REGN17092
  • Drug: Matching Placebo
• Experimental: Cohort 7 Low SC Dose
  Randomized 6:2 for single ascending dose
  Interventions:

  • Drug: REGN17092
  • Drug: Matching Placebo
• Experimental: Expansion Cohort 1
  Randomized 3:1 for single ascending dose
  Interventions:

  • Drug: REGN17092
  • Drug: Matching Placebo
• Experimental: Expansion Cohort 2
  Randomized 3:1 for single ascending dose
  Interventions:

  • Drug: REGN17092
  • Drug: Matching Placebo
• Experimental: Expansion Cohort 3
  Randomized 3:1 for single ascending dose
  Interventions:

  • Drug: REGN17092
  • Drug: Matching Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 11, 2024): 40
• Original Estimated Enrollment (submitted: June 20, 2023): 128
• Estimated Study Completion Date: April 30, 2025
• Estimated Primary Completion Date: April 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

1. Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization as described in the protocol
2. Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening
3. Has a body mass index (BMI) between 18 and 31 Kg/m^2 (inclusive) at the screening visit
4. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram (ECG)s performed at screening and/or prior to administration of initial dose of study drug

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator as described in the protocol
2. Presents any concern to the investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
3. Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
4. Has history of alcohol or drug abuse as determined by the investigator
5. Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food

NOTE: Other protocol defined inclusion / exclusion criteria apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT05923424
• Other Study ID Numbers: R17092-HV-2312; 2023- 505041-52-00 ( Registry Identifier: EU CT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: Analytic Code
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• URL: https://vivli.org/

• Current Responsible Party: Regeneron Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Regeneron Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trial Management; Regeneron Pharmaceuticals

• PRS Account: Regeneron Pharmaceuticals
• Verification Date: March 2024